Apparatus and method for stabilization of procedural catheter in tortuous vessels

ABSTRACT

The use of bifurcated catheter is disclosed for stabilizing working catheters for carotid percutaneous intervention of vessels originating from a tortuous aortic arch, which uses guide wires that used to enable the catheters accessing the left or right carotid arteries (CA). Also disclosed is the use of two independent catheters or a catheter and snare wire within a single sheath, as well as the implementations, associated problems and corrective solutions to the identified problems. Further additional uses of the bifurcated catheter/dual catheter, for access to and treatment of other exemplary tortuous locations where stability of the procedural catheter would make a difference are also disclosed in the current application.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional application of co-pending U.S.patent application Ser. No. 15/227,189 entitled “APPARATUS AND METHODFOR STABILIZATION OF PROCEDURAL CATHETER IN TORTUOUS VESSELS”, filedAug. 3, 2016, which is a continuation-in-part application of co-pendingU.S. patent application Ser. No. 14/929,030 entitled “Apparatus andMethod for a Bifurcated Catheter for Use in Hostile Aortic Arches”,filed Oct. 30, 2015, and also claims priority to Provisional ApplicationNo. 62/352,353, entitled “Apparatus and Method for Stabilization ofProcedural Catheter in Tortuous Vessels”, filed Jun. 20, 2016, theentirety of which is herein incorporated by reference.

BACKGROUND 1. Field

The invention relates to improved methods and apparatus used in catheterbased interventional procedures, mainly involving hostile vessels, andaccess for semi-invasive procedures, such as stenting.

2. Related Art

Stenting of the carotid artery (CA) is relatively new to interventionalprocedures. It is a challenging procedure because accessing the left orright carotid artery can be dependent on the anatomical disposition ofthe aortic arch.

FIG. 1 illustrates the aortic arch. As shown in FIG. 1, the aorta 1includes an aortic arch region 3, a descending aorta 2, and aninnominate 4. Three types of arches shown in FIG. 1: Type I, Type II andType III arches. Also shown in FIG. 1 is the right subclavian artery(RSA) 5, left subclavian artery (LSA) 6, right common carotid artery(RCCA) 7 and left common carotid artery (LCCA) 8.

The arch types are defined by the height of the top of the aortic arch 3from the base location where the innominate 4 attaches to the aorta. Ina type I arch, the height is less than the diameter of the commoncarotid artery (CCA). Similarly, in a type II arch, the height of thetop of the arch 3 from the base of the innominate 4 is of the order of 1to 2 times the diameter of the CCA. In a type III arch, the height ismore than twice the diameter of the CCA. As the height of the archincreases the procedures within the carotid arteries become more andmore difficult due to the tortuous nature of the arterial connections tothe aorta at the arch.

In type III hostile aortic arches, the angle of origin of the innonimateartery or left common carotid artery can be very acute thus making theaccess of the left or right carotid arteries ostium difficult.Subsequent placement of a stent delivery system in a stable mode intothe arterial system above it therefore becomes more difficult. Thestenting procedure itself is meant to re-establish a more normalizedblood flow through the carotid and internal carotid artery into thebrain by opening up regions of the artery constricted by plaque depositswhich inhibit flow. The stents themselves can be self-expanding, balloonexpandable, bio-absorbable, and/or covered. The stent delivery systemsare designed to accommodate very acute bends but are reliant upon theguide catheter and guide wires and or embolic protection devices tostabilize them during deployment. Stents have been used to open“stenosis”—semi-occluded sections of the arterial system—for many years.They come in a wide variety and are designed for specific areas of thebody, these include: balloon expandable, self-expanding, covered andbio-absorbable stents. Stenting in the neck and procedures above theneck are challenging when confronted with a type III hostile aorta, inparticular stenting of the left or right carotid artery. During theinsertion, manipulation and stabilization of the stent deliverymechanism and during removal of the guide wire and secondary wire,injuries to the subclavian artery and the tortuous aortic arch canhappen. This can be caused by uncontrolled collapse of the sheath,embolic protection device (EPD) and stent/stent delivery system in theascending aorta during procedure. This type of prolapse can result inthe patient suffering cerebral embolism or stroke by dragging the fullydeployed EPD over the carotid stenosis. Further, dragging the guidewires over the tortuous arterial regions can cause cutting into thearterial walls or otherwise injuring the artery resulting in dissectionsand trauma to the vessels involved. These traumas can be dangerous tothe patient as they can ultimately directly affect blood flow by leakageat the dissections or by creating accumulation of thrombus, anorganization of blood cells, which is a natural reaction to vesselinjury. These may require additional procedures to repair and heal thedamaged artery walls and prevent problems.

Accordingly, what is needed is systems and methods to stabilize thesheath, the EPD and the stent delivery system within the carotidarterial system to reduce the injuries caused to the arterial wallsduring stenting and other minimally invasive treatment of the carotidarteries and above the neck procedures.

SUMMARY

The following summary of the invention is included in order to provide abasic understanding of some aspects and features of the invention. Thissummary is not an extensive overview of the invention and as such it isnot intended to particularly identify key or critical elements of theinvention or to delineate the scope of the invention. Its sole purposeis to present some concepts of the invention in a simplified form as aprelude to the more detailed description that is presented below.

In accordance with one aspect of the invention, systems and methods aredisclosed for the use of a twin catheters in single sheath (snarecatheter/snared wire and procedural sheath)—one for the stabilizationwire and the other for the procedure.

In accordance with another aspect of the invention, systems and methodsare disclosed for the implementation of the twin catheters/sheaths or acatheter and stabilization wire without the bifurcated catheter with aTuohy Borst adapter to prevent blood leakage.

In accordance with another aspect of the invention, systems and methodsare disclosed for the use of the single sheath to stabilize theprocedural catheter for use in procedures in adverse tortuous anatomyfor minimally invasive procedures through both venous or arterialaccess.

In accordance with another aspect of the invention, systems and methodsare disclosed for the use of the bifurcated sheath and the dual sheathfor in treatment of contralateral lower extremity peripheral arterialdisease with a complex or hostile aortic bifurcation (due to a fixed andnarrow aortic bifurcation, iliac stenosis, ectasia, or tortuosity,aneurysm of the distal aorta, previous iliac stenting, previousendovascular aneurym repair and previous aortofemoral/aortoiliac bypassgrafting etc.) using bilateral groin access, renal and other visceralinterventions such as renal and SMA, stenting and cancer hepaticembolizations, and splenic arterial interventions (using groin andradial artery access).

In accordance with another aspect of the invention, systems and methodsare disclosed for the use of the bifurcated side hole catheter or the‘Y’ catheter for providing stabilization to the procedural catheterduring procedures where tortuous branching of vessels make stabilityimportant, such as:

1. Use in complex or hostile aortic bifurcation application.

2. Use in Visceral Interventions.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated into and constitute apart of this specification, illustrate one or more examples ofembodiments and, together with the description of example embodiments,serve to explain the principles and implementations of the embodiments.

FIG. 1 is a schematic diagram illustrate the three types of aorticarches encountered in humans.

FIG. 2 is a schematic diagram illustrating a distal end of a device witha snare wire extended from the main guide catheter capturing astabilization wire from the subclavian artery (SA) in accordance withone embodiment of the invention.

FIG. 3 is a schematic diagram illustrating the aortic arch with astabilization guide wire snared and pulled into the main guide catheterand out the proximal end in accordance with one embodiment of theinvention. The bifurcated catheter may or may not be at this stagelocated just inside the distal tip of the main guide catheter. Thebifurcated catheter in one embodiment may be advanced over the wireafter step S808A (FIG. 8A) while in another embodiment the bifurcatedcatheter may be pre-loaded at the distal tip of the main guide catheter(FIG. 8B).

FIG. 4 is a schematic diagram illustrating a reverse curve diagnosticcatheter with a guide wire coming out of in the distal tip of the mainguide catheter and up into the left common carotid artery in accordancewith one embodiment of the invention. In one embodiment, the reversecurve diagnostic catheter with the guide wire is extended out of thesheath or the main guide catheter, and in another embodiment, thebifurcated catheter is at the distal tip of the main guide catheter andthe reverse curve diagnostic catheter with the guide wire comes out ofthe larger leg of the bifurcated catheter.

FIG. 5 is a schematic diagram illustrating removal of a reverse curvediagnostic catheter, leaving behind a stiff guide wire in the leftcommon carotid artery in accordance with one embodiment of theinvention.

FIG. 6 is a schematic diagram illustrating a bifurcated catheter beingadvanced out of a main guide catheter over respective guide wires, thelarge over the stiff guide wire into the left common carotid artery andthe small leg being advanced over the guide wire into the rightsubclavian artery in accordance with one embodiment of the invention.

FIG. 6A is a cross-sectional view of a portion of the bifurcatedcatheter in accordance with one embodiment of the invention.

FIG. 7 is a schematic diagram of the legs of the bifurcated catheteradvanced out of the main guide catheter and parked into their respectivevessels in accordance with one embodiment of the invention. In someembodiments, the atraumatic tips are removed from each leg and thestabilized catheter is ready for procedures.

FIG. 8A is a flow chart of a procedure for stabilizing the processcatheter and stenting systems in accordance with one embodiment of theinvention.

FIG. 8B is a flow chart of a procedure for stabilizing the process andstent catheters in which one of bifurcations of the pre-loadedbifurcated catheter is used to accommodate the snare/stabilizationcatheter in accordance with one embodiment of the invention.

FIG. 9 is a schematic diagram showing the snare wire extended from aprotective sheath through the subclavian artery (AS) in accordance withone embodiment of the invention.

FIG. 10 is a schematic diagram showing a wire extended out of a sidehole of the initial reverse curve diagnostic catheter to be captured bythe snare in accordance with one embodiment of the invention.

FIG. 11 is a schematic diagram illustrating capturing the stabilizationwire by the snare wire loop in accordance with one embodiment of theinvention.

FIG. 12 is a schematic diagram of the extension of a stiff guide wirefrom the reverse curve Simmons catheter into the carotid artery inaccordance with one embodiment of the invention.

FIG. 13 is a schematic diagram showing the removal of the reversecatheter leaving the guide wire and the stabilization wire in place inaccordance with one embodiment of the invention.

FIG. 14 is a schematic diagram of the working sheath catheter, having anatraumatic tip and the working sheath catheter having a second chamberfor the guide wire extending out of a side hole, being advanced over theguide wire in accordance with one embodiment of the invention.

FIG. 15 is a schematic diagram of the working sheath catheter advancedto the location of the procedure and the guide wire removed in readinessfor a procedure in accordance with one embodiment of the invention.

FIG. 16 is a flow diagram for stabilizing the process catheters andsystems in accordance with one embodiment of the invention.

FIG. 17 is a corrective solution for leakage when using twin catheterssheaths or a catheter and a snare wire, by using a Touchy Borst Adapterof the correct size to prevents the possible leakage problem inaccordance with one embodiment of the invention.

FIG. 17A illustrates a solution to provide stabilization to theprocedural catheter or sheath in accordance with one embodiment of theinvention.

FIG. 18 is a pictorial representation of the initial step of inserting amain sheath and a reverse curve catheter from the right common femoralartery to access the left common iliac artery and introducing astabilization wire from the left common femoral artery in accordancewith one embodiment of the invention.

FIG. 19 is a pictorial representation of establishing a thick guide wireinto the left common Iliac in accordance with one embodiment of theinvention.

FIG. 20 is a pictorial representation of the snaring of thestabilization wire by a snare inserted through the main sheath while thethick guide wire is extended down the left superficial femoral artery inaccordance with one embodiment of the invention.

FIG. 21 is a pictorial representation of introduction of the bifurcatedcatheter (the side hole catheter) through the main sheath over the thickguide wire while the stabilization wire is carried through the side holeof the bifurcated side hole catheter in accordance with one embodimentof the invention.

FIG. 22 is a pictorial representation of the bifurcated catheter withthe bifurcation/side hole at the access point of the stabilization wireproviding end to end stabilization for the procedural catheter which isextending into the left superficial femoral artery in accordance withone embodiment of the invention.

FIG. 23 is a pictorial representation of the main sheath being extendedto the side hole location of the bifurcated catheter to improvestability of the procedural catheter while the procedural catheter fromthe bifurcated catheter extending into the left superficial artery readyfor aorto-bifemoral bypass application in accordance with one embodimentof the invention.

FIG. 24 is a pictorial representation of inserting a main sheath fromthe right common femoral artery with a snare that is used to capture thestabilization wire from left radial artery in accordance with oneembodiment of the invention.

FIG. 25 is a pictorial representation showing the stabilization e inplace and a reverse curve catheter being used to deploy a stiff guidewire into the left renal artery in accordance with one embodiment of theinvention.

FIG. 26 is a pictorial representation showing the bifurcated catheterextending out of the main sheath with the stabilization wire through thenarrow opening/catheter and the procedural catheter along the thick wirefrom the wider opening in accordance with one embodiment of theinvention.

FIG. 27 is a pictorial representation of the stabilized proceduralsection of the bifurcated catheter ready for visceral interventions inthe left renal artery in accordance with one embodiment of theinvention.

FIG. 28 is a pictorial representation of an antegrade femoral procedurein accordance with one embodiment of the invention.

DETAILED DESCRIPTION

Embodiments of the invention are directed to new devices and associatedmethods for the placement of stents in the carotid artery, andespecially into the left or right carotid arteries, for procedures abovethe neck. These new devices and associated methods stabilize the workinglumen or delivery sheath for the carotid stent delivery system. Thesenew devices and associated methods also protect the innominate andsubclavian artery as well as the aortic arch from trauma during stentingand other procedures above the neck where there is a possibility fortrauma to the arteries as a result of tension on the secondary orstabilization guidewire. This is especially true in the case of patientswith type II and Type III aortic arch.

Embodiments of the invention are directed to the application and use ofguide wires for stabilization of the catheters used to access the leftor right carotid arteries (CA) for carotid percutaneous intervention ofthe vessels originating from a tortuous aortic arch.

Embodiments of the invention use a bifurcated catheter having a maincatheter arm that is used to extend into the region of the procedure anda support catheter arm that extends into the right subclavian artery toprovide protection to that vessel during tightening of a support andstabilization wire through the right subclavian artery. The head of asheath/guide catheter is at that time placed in the aorta, at thebranching of either innominate or the left or right carotid arterythrough which the procedural arm of the bifurcated catheter, that is thesecond branch of the bifurcated catheter, has to be extended to conductthe procedure or place the stent. The correct placement of the head ofthe sheath catheter and the extension of the support catheter to coverthe support wire enable the wires to be extended and retracted withoutdamage to the arch and the arterial vessels used during procedure.

In some embodiments, the bifurcated catheter includes a main catheterthat divides into two separate catheters forming a “Y” shape. One leg ofthe bifurcated catheter has a smaller diameter with a smaller workinglumen (inner diameter) to carry the stabilizing wire and the second legof the bifurcated catheter has a larger working lumen for arterialstenting operations/procedures. This bifurcated catheter addresses thepercutaneous intervention related trauma to the vessels that arise fromtype-II or type-III hostile aortic arches, from uncontrolled prolapse ofthe sheath, embolic protection device and stent delivery system, bystabilizing the systems, using a through-and-through stabilization wirefor applying tension during stenting of the left and right carotidarteries.

Similar to type III aortic arches, tortuosity due to a bovine arch(origin of left common carotid artery from the innominately arteryrather than directly from the antic arch), tortuousity of the commoncarotid artery and even internal carotid artery (including angulatedtakeoff of the internal carotid artery) may be quite amenable to thedisclosed unique sheath system. In addition, standard technique dependson placing a stiff wire in the external carotid artery for support toadvance the sheath into the distal common carotid artery. The sheathdescribed herein circumvents the need for an external carotid arteryaccess which is otherwise crucial for the standard technique. Also, thedevice, due to its unique stability, may also allow larger caliberproximal protection devices (which depend on reversal of internalcarotid flow during stenting to prevent cerebral embolization) to bedeployed more easily. Similarly, the bifurcated catheter is useful incomplex or hostile aortic bifurcation application and visceralinterventions.

In one embodiment, a sheath catheter is percutaneously inserted at thegroin and directed through the descending aorta to the aortic arch. Asnare is inserted through the sheath and linked with a 0.014 inch or0.018 inch guide wire from the right subclavian artery (via the rightradial or brachial artery access) to provide a stabilization wire forthe operational catheter. At this stage, the stabilization wire and themain guide wire occupy the sheath catheter. A reverse curve catheter isthen inserted through the sheath catheter over the main guide wire,parallel to the stabilization wire and guided to the common carotidartery from the aortic arch. A stiff guide wire is then inserted throughthe reverse catheter to the location of the procedure. The reverse curvecatheter is then removed leaving the guide wire in the location of theprocedure. The bifurcated catheter is then guided to the aortic archwith one stabilization leg over the stabilization wire and the otheroperational leg over the stiff guide wire such that the operational legis guided into the common carotid artery while the stabilization leg isguided over the stabilization wire into the subclavian artery. The stiffguide wire is then removed leaving the operational leg of the bifurcatedcatheter in place for treatment procedures.

In one embodiment, a secondary stabilization wire having a smalldiameter, e.g., 0.014 or 0.016 inch, is guided through a, for example,Fr-3 or Fr-5, micro sheath, which is placed percutaneously through theright radial or brachial artery and threaded through the subclavianartery and snared into the main guide catheter to stabilize the distaltip. This way, the tension can be applied to the distal tip of the guidecatheter to stabilize it in a more planar orientation by putting tensionon the stabilization wire, as discussed above, to aid in thestabilization of the guide catheter, which is placed under fluoroscopy(C Arm) in the aorta using percutaneous access. This secondarystabilization wire is hence inserted into the right radial or brachialartery and guided through the right subclavian artery and down and outof the guide catheter. Though the description is provided for thesecondary access via the right radial of brachial artery, it should notbe considered limiting. It is possible to provide the secondary accessvia the left radial or brachial artery, external carotid artery orcommon carotid artery (instead of just the right radial or brachialartery). It may also be possible to have more than one accessory accessto complete the procedure using the device. Once the stabilization wireis established, a tension is applied to one or both ends of thesecondary stabilization wire to help stabilize the distal end of theguide catheter during the accessing of the left or right internalcarotid artery. This allows the stent delivery system to track moreeasily through the acute anatomy of the arch, especially one such as atype III arch.

In another embodiment, the bifurcated catheter is pre-loaded into theend of the main guide catheter or long sheath. In this embodiment, thebifurcated catheter has a procedural lumen and a second lumen that canaccommodate a snare catheter and wire. It will be appreciated, however,that a potential disadvantage of this device is that the catheter willneed to be a bigger device to accommodate the two lumens, but theadvantage is that it separates the wires from the beginning so that thewires do not inadvertently wrap around each other during the procedureand cause problems. In this embodiment, the guide catheter is providedwith a bifurcated distal configuration having two legs in the form of aY at the distal end. One leg is of a large diameter, typically having aninner diameter or “working lumen” sufficient to allow the passage of astent delivery system or other therapeutic devices. The second leg is ofa smaller diameter than the first leg with an inner diameter sufficientto accept a snare wire and snare the stabilization guide wire. Thisbifurcated catheter is sized so as to fit easily through the main guidecatheter placed at the start of the procedure and is of sufficientlength so as to allow the main leg of the bifurcated catheter to beplaced into the carotid artery for stenting and other procedures thereand above the neck. The secondary leg is of sufficient length so as tobe placed over a stabilization wire from the right subclavian artery andcover it sufficiently to prevent damage to the vessels it passes throughwhile providing the necessary stabilization to the main guide catheterand the bifurcated catheter, during procedural manipulations. Both legsof the bifurcated catheter need not be of the same stiffness ordurometer to be able to navigate their respective vessels. For instancesthe main carotid leg may be of a lesser durometer so as to navigate thearch into the selected carotid artery without affecting the naturalanatomic configuration whereas the small leg may be stiffer so as tohelp with the stabilization of the main guide catheter.

In one embodiment, another practical device and method for safelyaccessing the carotid artery is disclosed. In this a first reverse curvecatheter is inserted percutaneously and directed into the right or leftcommon carotid artery (RCCA or LCCA). A secondary wire is inserted inthe reverse curve catheter and out of a hole in the catheter at thelocation of the arch to be captured by a snare wire that is extended outof a protective sheath extended through the subclavian artery (typicallyvia right radial artery access). Once the snare has captured thestabilization wire a more rigid guide wire is extended through thereverse catheter into the common carotid artery towards the location ofthe procedure. The reverse catheter is then removed leaving both therigid guide wire and the stabilization wire in place. Asheath/procedural catheter with a conical atraumatic tip and also havingtherein a second chamber with a hole close to the distal end forproviding an exit for the stabilization wire is advanced over the guidewire and stabilization wires to the aortic arch and the sheath catheteris extended on to the location of procedure. Tension is applied to thestabilization wire for providing support to any working catheter that isinserted through the sheath catheter after removal of the stiff guidewire for conducting the procedure as needed.

In some embodiments, a sheath cover may be used for the stabilizationwire as it extends into the subclavian artery when tension is appliedprevent unwanted damage to the artery. The stabilized main sheath helpsthe procedure to be completed and the operational catheter and thesheath catheter to be removed safely.

In some embodiments, a reverse curve guide catheter with a lumen largeenough for stenting is used to select the common carotid artery. Asecondary wire is inserted in the reverse curve catheter through aparallel lumen in the reverse curve catheter and out of a hole in thecatheter at the location of the arch. This secondary wire is thencaptured by a snare wire with a loop that is extended out of aprotective sheath extended through the subclavian artery, typicallyinserted via right radial artery access. The carotid stenting procedurecan now proceed in the standard way described above since the reversecurve guiding catheter itself is stabilized and is usable for procedure.

Further to the above, the bifurcated catheter is ideal for providingstabilization to the procedural catheters used in treatment ofcontralateral lower extremity peripheral arterial disease with a complexor hostile aortic bifurcation (due to a fixed and narrow aorticbifurcation, iliac stenosis, ectasia, or tortuosity, aneurysm of thedistal aorta, previous iliac stenting, previous endovascular aneurymrepair and previous aortofemoral/aortoiliac bypass grafting) usingbilateral groin access.

In percutaneous procedures of the vessels originating from a tortuousaortic arch, the use of stabilization wires in addition to guide wiresto guide and stabilize the delivery catheters used to access the left orright carotid arteries is disclosed. The need for the stabilization ofthe sheath, the embolic protection device (EPD) and the stent deliverysystem (SDS) is to prevent the uncontrolled prolapse of the sheath, EPDand SDD during stenting procedure in the ascending aorta. This type ofprolapse can result in cerebral embolism or stroke in patients by thedragging of the fully deployed EPD across critical carotid internalartery stenosis. Embodiments of the invention provide for stabilizingthe sheath, the EPD and the SDS within the left or right carotidarteries by providing a secondary stabilization wire that holds theprimary sheath in place within the tortuous aortic arch during theprocedure, thereby providing the necessary stability for the SDS withinthe carotid artery during the procedure. These stabilizing wirestypically originate from a low profile radial or brachial artery accessand provide a through-and-through tension and support to the sheath byenabling the application of tension to one or either end of thestabilization wire through a typical micro-sheath or catheter. In thisembodiment the brachial artery or a small radial artery is usable withthe micro-sheath, and similarly in the case of another embodimentdescribed the sheath catheter is used to puncture the radial artery orthe brachial artery for entry, to provide adequate hemostasis whilekeeping the entry profile low. In one embodiment, the stabilization wirehas a small diameter, e.g., 0.014 or 0.018 inch diameter, themicro-sheath has a 3 Fr. Diameter, and the sheath catheter has a 5 Fr.Diameter. The use of the small size wire and micro-sheath is useful inpreventing hematoma in the brachial artery, which can be devastating inpatients receiving anticoagulation drugs, such as Heparin, andanti-platelet therapy such as Plavix, during or after the procedure. Thestabilizing wire from the brachial artery enters the aortic arch throughthe right subclavian artery to be captured and brought out through thesheath at its proximal end. Due to their diameter and forces appliedduring the procedures, the guide wires, if used without proper coveringcan inadvertently cause trauma to the associated tortuous vessels walls.The bifurcated catheter disclosed herein provides the necessaryprotection to the arch and the subclavian artery while providing thenecessary stabilization to the sheath, SDS and EPD for access andprocedures within the carotid arteries, especially for above the neckprocedures. The bifurcated catheter disclosed includes a main catheterthat divides into two separate catheters forming a “Y” shape. One leg ofthe catheter has a smaller diameter with a smaller working lumen (innerdiameter), to carry the stabilizing wire, than the second leg of thecatheter that has a larger working lumen for arterial stentingoperations. This device provides the necessary stability to the systemfor stenting of the carotid arteries while addressing the percutaneousintervention related trauma to the vessels associated with type-IIIhostile aortic arches that arise therefrom. Multiple embodiments of theinvention are described here under. Even though in the examplesdescribed the secondary access is shown as being established via theright radial or brachial artery, it should not be considered limiting inany way. The secondary access may be established via any of the leftradial or brachial artery, external carotid artery or common carotidartery (instead of just the right radial or brachial artery). It mayalso be possible to have more than one accessory access to complete theprocedure using the device.

A first embodiment of the invention is described with reference to theschematic diagrams shown in FIGS. 2 to 7 and the flow chart of FIG. 8A.This embodiment illustrates the ability to conduct procedures such asstenting in the left internal carotid artery (LICA) 16 using aprocedural catheter that can be inserted through the aortic arch 13 andleft common carotid artery 15.

As shown in FIG. 2, a sheath catheter 18 is initially insertedpercutaneously and guided using fluoroscopic tracking using the opaquemetal ring 20 at its distal end. In one embodiment, the sheath catheter18 is a 7 French (Fr) or 8 Fr sheath; it will be appreciated thatdifferently sized sheath catheters may be used as known to those ofskill in the art. The sheath 18 is guided through the femoral artery andthe descending thoracic aorta 12 to the aortic arch 13. A snare wire isinserted through the sheath 18 and extended to the aortic arch 13 with asnare loop 21. In one embodiment, the snare loop has a diameter that isany value or range of values between about 20 to 30 mm; it will beappreciated that the diameter may be less than about 20 mm or greaterthan about 30 mm.

A second stabilization wire 19 is inserted through the radial artery andguided through the subclavian artery 14 to the aortic arch 13. In oneembodiment, the second stabilization wire has about a 0.014 inchdiameter. The stabilization wire 19 is captured by the snare 21 and thenpulled into the sheath catheter 18, as shown in FIG. 3. In oneembodiment, the snare 21 pulls the stabilization wire such that it exitsthe proximal end of the sheath 18 to form a through-and-throughstabilization wire. In one embodiment, a 3 Fr. to 5 Fr. sheath may beused over the 0.014 stabilization wire 19 to reduce slicing and traumato the arteries the wire is guided through.

A reverse curve catheter 24 with an atraumatic tip is then inserted inparallel with the stabilization wire 19 through the sheath catheter 18,as shown in FIG. 4. The reverse curve catheter 24 is used to select theleft common carotid artery 15. A stiff wire 23 is then inserted throughthe reverse curve catheter 24 to the site of the procedure. In oneembodiment, the stiff wire has an approximately 0.035 inch diameter.

Next, the reverse curve catheter 24 is removed, leaving the stiff wire23 in the area of the procedure and the stabilization wire 19 in place,as shown in FIG. 5. Both the stiff wire 23 and stabilization wire 19occupy the large sheath catheter 18, as shown in FIG. 5.

A bifurcated catheter having bifurcations 25 and 26 is then advancedover both the stiff wire 23 and the stabilization wire 19 respectivelyand out of the guide catheter 18. The large leg (or bifurcation) 25which contains a procedural catheter tracks along the stiff guide wire23 into the left common carotid artery 15. The small leg (orbifurcation) 26 tracks along the stabilization wire 19 coming from theright subclavian/innominate artery. Both legs 25, 26 have atraumatictips 28 to reduce trauma, as shown in FIG. 6.

FIG. 6A is a cross-sectional view of a portion of the bifurcationcatheter within the sheath catheter 18. The bifurcation catheterincludes a common catheter portion that bifurcates into two separatebifurcations or legs 25, 26 at junction 30. As shown in FIG. 6A, each ofthe bifurcations of legs 25, 26 include lumens that extend from a distalend of the bifurcation catheter to a proximal end of the bifurcationcatheter. As shown in FIG. 6A, the bifurcated leg 25 is configured toslideably receive the guidewire 23, and the bifurcated leg 26 isconfigured to slideably receive the stabilization wire 19.

Once the bifurcated catheter is in place, the stiff wire and theatraumatic tips are removed and tension is applied to the stabilizationwire from both ends to stabilize and position the operational end of thebifurcated catheter, as shown in FIG. 7.

The bifurcated catheter is now ready for stenting or other procedures inthe left internal carotid artery 16.

FIG. 8A illustrates the process 800A described above with reference toFIGS. 2-7.

The process 800A begins by inserting a sheath catheter 18 catheterthrough the groin access and guided using radiographic imaging using theopaque ring 20 at its distal end through the descending aorta 12 to alocation in the aortic arch 13 suitable for access into the left commoncarotid artery 15 (block S801A).

The process 800A continues by inserting and advancing a snare wirethrough the sheath catheter 18 and out its distal end into the aorticarch 13 (block S802A).

The process 800A continues by inserting a second stabilization guidewire 19 through the radial artery and guiding it through the rightsubclavian artery 14 to the aortic arch 13 (block S803A).

The process 800A continues by using the snare loop 21 of the snare wireto capture the guide wire 19 and pull it through the sheath catheter 18to its proximal end to provide an end-to-end stabilization wire overwhich tensions can be applied (block S804A).

The process 800A continues by advancing a reverse curve catheter 24 upthe lumen of the sheath catheter 18 and into the left common carotidartery 15, again using the opaque ring 25 at its distal end (blockS805A).

The process 800A continues by advancing a reasonably stiff guide wire 23up the reverse curve catheter 24 and into the left common carotid artery15 to the location of the procedure near the left internal carotidartery 16 (block S806A).

The process 800A continues by removing the reverse curve catheter 24,leaving the stabilization wire 19 and the stiff guide wire 23 in place,both occupying the lumen of the sheath catheter 18 (block S807A).

The process 800A continues by inserting a bifurcated catheter having amain operational leg 25 over the stiff guide wire 23 and having astabilization leg 26 over the stabilization wire 19 (block S808A).

The process 800A continues by advancing the bifurcated catheter havingatraumatic tips 28 on the end of the main operational catheter leg 25 tothe aortic arch 13 through the sheath catheter 18 (block S809A).

The process 800A continues by advancing the main operational leg 25 tothe location of the procedure by advancing the main operational catheterleg 25 over the stiff wire 23 (block S810A).

The process 800A continues by extending the second leg 26 of thebifurcated catheter over the stabilization wire 19 through theinnominate and the subclavian artery 14 (block S811A).

The process 800A continues by removing the stiff wire 23 and theatraumatic tips 28 and applying tension to the stabilization wire 19 tostabilize the working lumen leg 25 at just below the left internalcarotid artery 16 (block S812A).

The process continues by performing any treatment procedure, includingstenting of the left internal carotid artery 16, through the mainoperational catheter leg 25 (block S813A).

In another embodiment, the bifurcated catheter accommodates the snarecatheter in the secondary lumen. In this embodiment, one leg 25 of thebifurcated catheter is used as the procedural catheter and the other legof the bifurcated catheter 26 is used initially to send in the snareloop 21 and capture the stabilization wire 19. A reverse curve catheter24 is sent through the procedural leg 25 of the bifurcated catheter intothe LCCA 15 or RCCA and the stiff guide wire 23 is placed at thelocation of the procedure site. The second leg of the bifurcatedcatheter already at the aortic arch 13 is equipped with an atraumatictip 28 and guided along the wire 23 to the location of the procedure. Atthe same time, the first leg 26 of the bifurcated catheter is extendedto cover the stabilization wire 19 into the subclavian artery 15. Theatraumatic tip 28 and the stiff wire 23 are then removed and the secondleg 25 of the bifurcated catheter is ready for the next treatment stepsat the site, including stenting or other procedures. This embodiment isfurther described with reference to FIGS. 2-7 and FIG. 8B.

In this embodiment, a bifurcated catheter is inserted with the mainsheath catheter. In this embodiment, the bifurcated catheter has twochambers therein, one for the procedure and the second chamber for thesnare catheter, snare loop/wire, and stabilization wire. This enablespassing a snare catheter, snare loop/wire and stabilization wire allthrough a second chamber/branch of the bifurcated catheter when it is atthe apex of the curve of the aortic arch similar to the processdescribed earlier. The process is described below with reference toFIGS. 2-7 and flow chart 800 b of FIG. 8B.

FIG. 2 illustrates the distal end of sheath catheter device 18, showingthe distal end 20 of the device percutaneously inserted and advancedthrough the descending thoracic aorta 12 to the aortic arch 13. Thebifurcated catheter (not shown) is inserted with the sheath catheter andadvanced to the aortic arch 13. A snare wire with a 20 to 30 mm snare isshown extended from the sheath catheter in FIG. 2. In this embodiment,the snare is within the smaller chamber of the bifurcated catheterwithin the sheath catheter. The snare captures a stabilization wire 19that is extended into the aortic arch 13 from the right subclavianartery (RSA) 14, as shown in FIG. 2. FIG. 2 further shows the ascendingaorta 11, the LCCA 15, the left internal carotid artery 16 and the heart50.

FIG. 3 shows the snare being tightened 22. In this embodiment, thesnared stabilization wire 19 is pulled into the smaller lumen of thebifurcated catheter (not shown) and to the proximal end of the same toprovide and end-to-end stabilization for the procedural catheter.

FIG. 4 shows a reverse curve catheter 24 such as a Simmons catheter witha stiff wire 23 being extended from the sheath catheter 18. The reversecurve catheter 24 is extended through the second, larger chamber of thebifurcated catheter into the CCA 15 and advanced to the site of theprocedure at just below the left internal carotid artery 16.

The left carotid artery is shown in the figures but it is not meant tobe limiting as procedures in both right and left carotid can beaddressed with this implementation. Also the carotid artery may beselected with the same reverse guide catheter and a softer guidewire.Once selection has occurred the softer guidewire may be exchanged forthe stiffer guidewire.

FIG. 5 shows the stiff wire/guide wire 23 being left at the intendedsite of the procedure after removal of the reverse catheter.

FIG. 6 shows the bifurcated catheter being advanced with the large lumen25 over the stiff wire 23 to the site of the procedure and the smalllumen 26 over the stabilization wire 19. An atraumatic tip is used toreduce trauma to the artery during this catheter advance.

FIG. 7 shows the catheter 25 with the wire and the atraumatic tipsremoved and ready for the procedure. Stabilization for the processcatheter is provided by applying tension to the stabilization wire 19,to stabilize and fix the location of the sheath catheter and theposition of the bifurcation.

FIG. 8B illustrates a process 800B for stabilizing and fixing thelocation of the sheath catheter and the position of the bifurcationcatheter in accordance with one embodiment of the invention.

The process 800B begins by inserting a guide wire 23 through the femoralartery percutaneously (block S801B).

The process 800B continues by advancing the guide wire 23 through thedescending thoracic aorta 12 to the aortic arch 13 using radiographicimaging (block S802B).

The process 800B continues by inserting a guide or sheath catheter 18having a platinum ring 20 that is opaque to X-ray at its distal endthrough the groin access and guiding the sheath catheter 18 through thedescending aorta over the guide wire to the aortic arch 13 to a locationsuitable for access into the left common carotid artery 15 and the leftinternal carotid artery 16 that is being accessed for the procedureusing x-ray fluoroscopy (block S803B).

The process 800B continues by inserting the larger leg of the bifurcatedcatheter 25 with the smaller leg 26 arranged parallel to it and guidingthe bifurcated catheter over the guide wire 23 to the distal edge 20 ofthe sheath catheter 18 (block S804B).

The process 800B continues by inserting a stabilization guide wire 19through the brachial artery preferably using a micro sheath andadvancing the stabilization guide wire 19 through the right subclavianartery 14 into the aortic arch 13 (block S8054).

The process 800B continues by extending a second segment of thestabilization guide wire having a snare 21 at its distal end out of thesmaller leg 26 of the bifurcated catheter to capture the stabilizationwire 19 from the subclavian artery and pull it through the smaller legof the bifurcated catheter and out to its proximal end providing an endto end stabilization wire for stabilizing the sheath and the bifurcatedcatheter (block S806B).

The process 800B continues by advancing a reverse guide catheter 24through the tortuous connection of the left common carotid artery 15 tothe aorta at the aortic arch 13 over a reasonably stiff wire 23 up theworking lumen of the larger leg of the bifurcated catheter through theleft common carotid artery 15 just below the left internal carotidartery 16 where the procedure is to be carried out (block S807B).

The process 800B continues by removing the reverse guide catheter 24 andleaving the stiff guide wire 23 in place as a guide to the bifurcatedcatheter (block S808).

The process 800B continues by advancing the bifurcated catheter out ofthe guide catheter, the large leg 25 of the bifurcated catheter trackingalong the stiff guide wire 23 into the left common carotid artery 15 andthe small leg 26 tracking along the guide wire 19 coming from the rightsubclavian/innominate artery (block S809).

The process 800B continues by removing the guide wire 23 and theatraumatic tips 28 and applying tension to the stabilization wire 19 tostabilize the main catheter leg 25 extending to just below the leftinternal carotid artery 16 (block S810).

The process 800B continues by performing a treatment procedure, such asstenting or other procedures as needed, at the treatment site (blockS811).

FIGS. 9 to 15 and FIG. 16 illustrate another embodiment of the inventionin which a modified snare bifurcated sheath with a side hole is usedinstead of the bifurcated catheter to provide stability to theprocedural catheter used for stenting and other procedures in thecarotid arteries. In this embodiment, the snare loop is inserted throughthe subclavian artery to capture the snare wire and provide athrough-and-through capability for stabilization of the proceduralcatheter. In some embodiments, the snare loop is inserted through thesubclavian artery via a right radial or brachial artery access.

FIG. 9 shows a snare wire 19 having a snare loop at its distal endinserted through the radial artery using a sheath 52 extended throughthe right subclavian artery 14 into the aortic arch 13. In oneembodiment, the sheath 52 is a Fr 5 sheath. In one embodiment, the snareloop 51 has a 30 to 40 mm diameter. A reverse curve catheter 53, such asa Simmons catheter, is inserted through the groin access and guidedthrough the descending aorta 12 to select the left common carotid artery15 (it can also be used to select the right carotid artery). In oneembodiment, the reverse curve catheter 53 is a Fr. 5 catheter.

FIG. 10 further shows a secondary stabilization wire 55 that is insertedfrom the proximal end of the reverse curve catheter 53 and exited out ofa hole 54 on the side of the catheter 53 at the location at the apex ofthe curve of the aortic arch 13. In one embodiment, the secondarystabilization wire has a 0.014 diameter.

FIG. 11 shows the stabilization wire 55 being snared by the snare 56 toprovide a tensionable stabilization capability comprising the snare 56from the sheath catheter 52 coming from the right subclavian artery andthe snared wire 55 coming from the reverse curve catheter 53.

FIG. 12 further shows a stiff guide wire 57 being extended from thereverse catheter 53 into the left common carotid artery 15 and below theleft internal carotid artery 16 where the procedure is expected to becarried out once the tensionable stabilization is established.

FIG. 13 shows the withdrawal of the reverse catheter 53 leaving both thesnare 56, snared stabilization wire 55, and the stiff guide wire 57 intothe left common carotid artery 15, and below the left internal carotidartery 16.

FIG. 14 shows a bifurcated sheath catheter 58 having two chambers—onefor the stabilization wire and the other for the process catheter withan atraumatic dilator tip 59, being guided over the stiff guide wire andthe stabilization wire 55, which exits the sheath through a hole 60, inthe sheath catheter 58. In one embodiment, the bifurcated sheathcatheter 58 is a Fr.6 or Fr.7 sized catheter.

FIG. 15 shows the sheath catheter 58 with the stiff wire and atraumatictip removed with the snared stabilization wire 55, forming an end-to-endwire enabling stabilization tension to be applied to stabilize thesheath catheter 58 extending into the left internal carotid artery 16for inserting the procedural catheter for stenting and other proceduresfrom the aortic arch 13.

In yet another embodiment, the initial sheath catheter may have twolumens, one for the support and stabilization wire and a second as theoperational catheter. Further, the operational catheter may be made witha softer operational leg at its distal end which can be used as areverse curve guiding catheter as well. By combining the applicationcapabilities of such a catheter, it is possible to reduce the number ofcatheters used and hence the number of steps needed for set up andcompletion of the procedure.

FIG. 16 is flow chart illustrating a process 1600 according to anotherembodiment of the invention.

The process 1600 begins by inserting a wire with a snare 51 through asheath 52 that is inserted through the radial artery and directedthrough the right subclavian artery 14 such that the snare is in theaortic arch 13 (block S1601).

The process 1600 continues by percutaneously inserting and advancing areverse curve catheter 53 up the femoral artery into the descendingthoracic aorta 12 into the left common carotid artery 15 usingradiographic imaging (block S1602).

The process 1600 continues by inserting a secondary stabilization wire55 into the reverse curve catheter 53 at the proximal end and exitedfrom a hole 56 near the distal end of the reverse curve catheter at theaortic arch 13 to be snared by the snare 51 from the subclavian artery14 (block S1603).

The process 1600 continues by snaring the stabilization wire 55 toprovide an end to end stabilization (55) to the catheter, and extendinga stiff guide wire 57 through the reverse curve catheter 53 into theleft common carotid artery 15 to the location of the procedure (blockS1604).

The process 1600 continues by removing the reverse curve catheter 53,leaving both the stabilization wire 55 and the stiff guide wire 57 inplace in the arteries (block S1605).

The process 1600 continues by advancing a bifurcated sheath catheter 58having two partitions (one for the stabilization wire 55 with a sidehole 60 near the distal end and another with a dilator tip 59 for theguide wire 57) over the two wires into position such that the sheathcatheter for process 58 is extended into the carotid artery 16 while thestabilization wire 55 through the hole 60 in the bifurcated sheathcatheter 58 extends from the proximal end of the sheath catheter 58through the hole 60, through the aortic arch 13 and subclavian artery 14to provide a through and through capability to provide tension andstabilization to the operating catheter 58 (block S1606).

The process 1600 continues by extending the sheath catheter into theleft internal carotid artery 16 to the location of the procedure (blockS1607).

The process 1600 continues by removing the stiff guide wire 57 and theatraumatic dilator tip 58 and tensioning the stabilization wire 55 toprovide stability to the sheath catheter 58 (block S1608).

The process 1600 continues by inserting the catheter for the procedurethrough the main chamber of the sheath 58 to the location of theprocedure in the left internal carotid artery 16 (block S1609).

The process 1600 continues by performing a stenting or other procedureat the treatment site (block S1610).

In another embodiment, a reverse curve catheter with a lumensufficiently large for stenting instead of a sheath catheter may beused. In this embodiment, the reverse curve catheter having two lumens,one large procedural lumen and the other a smaller stabilization lumen,is used to select the carotid artery. A secondary wire is inserted inthe reverse curve catheter (through the stabilization lumen) and out ofa hole in the reverse curve catheter at the location of the arch. Thissecondary wire is then captured by a snare wire with a loop that isextended out of a protective sheath extended through the subclavianartery. The carotid stenting procedure can now proceed in the standardway using the procedural lumen of the reverse curve catheter since thereverse curve guiding catheter itself is stabilized and is usable forprocedure.

Yet another implementation or embodiment is the use of two catheters ora catheter and a snare wire within a single sheath, as shown in FIG. 17,for providing the necessary stabilization to the catheter used for theprocedure. In the first embodiment, the second catheter contains thesnare wire that will be used to capture the stabilization wire andprovide the necessary stabilization to the catheter used for theprocedure. Alternately, the snare wire and a catheter are in a singlesheath. Though this twin catheter or the catheter 1707 and snare wire1708 may provide a solution it comes with a plurality of problems. Inthe case where two catheters are used, there is need for a larger sheathwhich will accommodate the twin catheters. In many cases, it is notpractical to use such a large sheath. In using twin catheters or acatheter 1707 and a snare wire 1708, there is a possibility forentanglement and twisting of the two independent catheters or thecatheter 1707 and the wire 1708. This can cause difficulty in properinsertion to the site as well as during extraction of the catheter 1707after the procedure. Also, in these cases, there is a possibility ofblood leakage from the access site, as is well understood by thesurgeons. In order to prevent the blood leakage, a Tuohy Borst adapteras shown in FIG. 17 is used. One access 1704 is made to fit the exactsize of the catheter 1707 and the other access 1705 is used to isolatethe snare wire used as shown. The Tuohy Borst adapter of FIG. 17 isattached by the adapter 1703 to a catheter handle 1702/1701 combination.The handle has a fixed holder portion 1701 connected to a manipulatorsection 1702.

The typical implementation of the embodiment having dual catheterswithout the Tuohy Borst adapter, due to the problems discussed, is notan optimum solutions and is not recommended over the more optimumsolutions disclosed. Another solution is the use of the proceduralcatheter 1707 and a snare wire 1708 within the same sheath 1706, Thissolution also has the major problem of entanglement of the wire with thecatheter, as the wire used is much lighter and less rigid than thecatheter, with the associated problems of insertion and extraction aswell as the problem of blood leakage as discussed previously. Hence,this is also not a recommended solution. As an example, the proceduremay be performed using a long 8 French 70 cm sheath with a coaxiallonger 6 French 90 cm catheter and a 0.18 or 0.14 inch snare wire. Inthis case, the procedure would be complicated by potential wire wrap ofthe 0.018 inch wire around the 6 French catheter causing entanglements.Furthermore, there would be persistent leakage of blood at the 8 Frenchsheath valve, similar to the twin catheter case, which has both the0.018 inch wire and 6 French catheter. This can be life threatening.

Another way to provide stabilization to the procedural catheter orsheath is shown in FIG. 17A. Here a modified sheath/reverse curve guidecatheter 24A is percutaneously inserted and advanced up the femoralartery through the descending thoracic aorta 12 into the aortic arch 13,using radiographic imaging as described previously. The modified sheathcatheter 18A is reinforced with graspable sections 62 for example: 62-1,62-2 and 62-3 shown at the appropriate locations using ferro-magneticmaterial. A second stabilization catheter 52A with a magnetic gripper MAthat is a latching mechanism is now introduced into the aortic arch 13using right subclavian artery 14 access via radial or brachial artery.The magnetic latching mechanism attaches to one of the graspablereinforced ferromagnetic sections 62 of the modified sheath catheter 18Ato provide stabilization to the modified sheath catheter 18A. A reversecurve catheter 24A is now used to access the left common carotid artery15 through the stabilized modified sheath catheter 18A as describedpreviously for establishing a path for the procedural catheter and forconducting the procedure as described previously.

In certain embodiments the modified sheath catheter 18A may be replacedby the reverse curve guide catheter 24A having the requiredmodifications and reinforcements for the gripper or latching mechanismto engage with it directly.

In certain other embodiment the gripper or latching mechanism is notmagnetic, but is a mechanical attach mechanisms that attaches to orgrips the reinforced portion of the sheath catheter 18A.

Though embodiments the invention has been described mainly as beingapplicable to the tortuous arterial procedures above the neck, it shouldnot be considered limiting. The bifurcated sheath can be modified totreat contralateral lower extremity peripheral arterial disease with acomplex or hostile aortic bifurcation (due to a fixed and narrow aorticbifurcation, iliac stenosis, ectasia, or tortuosity, aneurysm of thedistal aorta, previous iliac stenting, previous endovascular aneurysmrepair and previous aortofemoral/aortoiliac bypass grafting) usingbilateral groin access. It can also be useful for renal and othervisceral interventions such as renal and SMA stenting and cancer hepaticembolizations and splenic arterial interventions (using groin and radialartery access). The advantage of this device is that it can conqueradverse tortuous anatomy by providing stabilization during procedures inadverse tortuous anatomy for minimally invasive procedures through bothvenous or arterial access.

The use of disclosed bifurcated sheath, the dual sheath/catheter, orcatheter and stabilization wire, for in treatment of contralateral lowerextremity peripheral arterial disease with a steep aortobifemoral bypassgraft (using bilateral groin access), renal and other visceralinterventions such as renal and SMA, stenting and cancer hepaticembolizations, and splenic arterial interventions (using groin andradial artery access) are disclosed. Two examples of such use arediscussed below.

FIGS. 18-23 show the exemplary use of the bifurcated catheter with aside hole (the side hole catheter) for stabilization of the proceduralcatheter in Aorto Bifemoral Bypass application. The figures identify themain arterial branches that are involved—the left renal artery 1801 goesoff the abdominal Aorta 1802. The abdominal aorta 1802 bifurcates intothe right iliac 1803 and the left iliac 1804 both of which continue asright external iliac 1805 and left external iliac 1806 after the rightand left internal iliacs go off the tight iliac 1803 and left iliac1804. As they transition down the body the tight external iliaccontinues as the right common femoral artery 1807 and the left externaliliac continues as the left common femoral artery 1808 which furtherdown becomes the right superficial femoral 1809 and the left superficialfemoral a 1810. During aorto bifemoral bypass application as shown inFIG. 18 the main sheath 1820 access 1822 is made through the rightcommon femoral artery 1807 and stabilization wire 1825 of 0.14″ access1826 through the left common femoral artery 1808. As shown in FIG. 18and FIG. 19 the main sheath 1820 is extended into the right common iliac1803, close to the aortic bifurcation 1901 and a reverse curve catheter1824 with a thick guide wire 1821, typically of 0.35″, is insertedthrough the sheath 1820 and placed at the bifurcation 1901 as shown at1902 to gain access to the left iliac 1804. The thick guide 1821 is nowextended down the left iliac 1804 to the left common femoral artery1808. FIG. 20 shows the introduction of a snare catheter 2002 using asnare manipulator 2001 into the main sheath to have a snare 2003 at theaortic bifurcation 1901. The snare 2003 is used to capture thestabilization wire 1825 and pull it into and out of the main sheath 1820at the proximal end, to create an end to end stabilization capability.In FIG. 21, the reveres curve catheter 1824 is now removed and abifurcated or side hole sheath catheter 2101 is introduced through themain sheath 1820 with the thick guide wire 1821 through the larger armof the ‘Y’ catheter 2101 and guided over the thick guide wire 1821 suchthat the side hole 2102 of the bifurcated catheter 2101 is at the accesspoint on the LCFA 1808 of the stabilization wire 1825. The side hole ofthe bifurcated catheter 2101 carries the stabilization wire 1825. FIG.22 shows the main sheath 1820 extended over the bifurcated catheter 2101to the access point of the stabilization wire 1825, through the LCFA1808. FIG. 23 shows the use of the stabilization wire 1825 to anchor andstabilize the procedural catheter 2301 so that deeper penetration in astable way is made possible for procedures in the LSFA 1810.

FIGS. 24-27 illustrate an example of the use of the stabilizationtechnique using bifurcated sheath/catheter for visceral interventions.An intervention in the left renal artery 1801 is shown in these figures.The access of the main catheter 1820 as in the previous case is via theright common femoral artery 1807. The main sheath 1820 is guided up intothe abdominal aorta 1802 using the visibility provided by the radioopaque tip 1823. A snare 2003 is introduced through the main sheath 1820to capture a stabilization wire 2402. The access for the stabilizationwire 2402 is from the left radial artery through the aortic arch intothe abdominal aorta 1802. FIG. 25 shows the stabilization wire 2402snared and pulled into the tip of the main sheath, through the sheathand out of the proximal end of the main sheath. A common reverse curvecatheter 2501 is used to extent a thick guide wire 2404 into the leftrenal artery 1801. A version may be created whereby a thin guidewire mayalso be placed into the renal artery. The reverse curve catheter or anyselective renal/visceral catheter is removed leaving the guidewire inplace. The bifurcated ‘Y’ catheter or sheath (Hence forth ‘Y’ Catheter)is now loaded (outside the main sheath) with the smaller branch of thebifurcated ‘Y’ catheter advancing over the stabilization wire 2402 whilethe larger arm of the ‘Y’ catheter with its inner dilator is advancedover the thick wire 2404. FIG. 26 shows the bifurcated ‘Y’ catheteradvanced all the way through the main sheath 1820. FIG. 26 shows thesmaller branch of the bifurcated catheter (with its inner dilator)advancing over the stabilization wire 2402 with simultaneous advancementof the larger arm of the ‘Y’ catheter (with its inner dilator) over thethick guide wire 2404. FIG. 27 shows the bifurcated catheter 2702 isextended out of the main catheter 1820 with the smaller or narrow arm2602 moving up the abdominal aorta along the stabilization wire 2402 andthe wider arm 2603 moving further into the left renal artery 1801 readyfor any procedure needed after any inner dilators have been removed fromthe lumens. An inner dilator may not necessarily be needed for thesmaller lumen.

In another modification of the embodiment described above, a smallerdiameter main sheath may be used. The main bifurcated ‘Y’ sheath is notpreloaded into the main sheath. This allows the use of a 6 French snarecatheter through the main sheath lumen to grasp the stabilization wireand pull it all the way out through the proximal end or hub of thesheath. Next a reverse curve or renal/visceral selective catheter isadvanced through the sheath and out through the tip to select the leftrenal artery. A thick guide wire is left in place in the left renalartery and the selective catheter is removed. It should be understoodthat the 2 wires can each be separately loaded through the appropriatelumen of the ‘Y’ catheter. The ‘Y’ catheter can now be advanced as shownin FIG. 26.

Another need for stabilization of the procedural catheter or the sheathcarrying the procedural catheter is when using very long catheters toreach the location of the procedure. FIG. 28 shows such an application.As is well understood Retrograde, and especially antegrade femoralpuncture or access is very difficult in obese patients. Hence asuper-long radial artery sheath or super-long sheath that extends to theleft common femoral 1808 or the right common femoral 1807 or below-kneearteries such as right superficial femoral 1809 or left superficialfemoral 1810 is used for arterial interventions in the femoral artery ofthese patients. As sheaths become super-long they lack stability andpushability for common femoral artery and below-knee arterialinterventions, especially for chronic total occlusion traversals. Inthese cases it is possible to provide stabilization and improve thepushability to the super-long sheath carrying the procedural catheter2804 using the modified super-long sheath like the 2802 with reinforcedsections 2803 (2803-1 to 2803-4) and enabling a gripper or graspingattachment 2805 attached to a second stabilization catheter 2801 toattach the second stabilization catheter 2801 to the super-long sheath2802 to provide stability, FIG. 28 shows the super-long modified sheath2802 extending down the abdominal aorta 1802 to the left common iliacartery 1804 to the left external iliac 1804. The modified super-longsheath 2802 has reinforced gripper sections 2803-1 to 2803-4. Astabilization catheter 2801, with access from the right common femoralartery 1807 having s a mechanical gripper attachment 2805 at the end ismoved up the right common iliac 1803 to make contact with the modifiedsuper-long sheath 2802 at the apex of the fork of the iliac arteries andcapture one of the reinforced regions such as 2803-3. In an alternatecase, the magnetic attachment previously described may be used insteadof the mechanical gripper attachment. By capturing and getting attachedto the modified super long sheath 2802, the stabilization catheter 2801is able to enhance the stability and pushability to the modified superlong sheath 2802. The procedural catheter 2804 is now able to beextended into the left common and left superficial femoral arteries toconclude procedures. It should be noted that further stabilizationmethods already disclosed such as side hole stabilization orstabilization using bifurcated Y catheter, or even an additionalstabilization by use of a magnetic or mechanical gripper attachment maybe used in conjunction with the above, when needed to improve thesuccess of the procedure.

Though the above examples show specific examples with access points forthe procedural catheter and the stabilization catheter/wires, it is notmeant to be limiting. There may be other scenarios possible for accessand stabilization of procedural catheter or sheath depending on thelocation of the procedure and the nature of the patient. Thestabilization schemes proposed using either the bifurcated ‘Y’ catheter,the bifurcated side hole catheter or the dual catheter and the modifiedsheath catheter with the latching mechanism, are all usable to providestability where the procedures are conducted in tortuous branches ofmajor vessels. As is well understood the preferred method will varybased on the location of the procedure and the nature of the patient.

As will be understood by those familiar with the art, the invention maybe embodied in other specific forms without departing from the spirit oressential characteristics thereof. Likewise, the particular naming anddivision of the members, features, attributes, and other aspects are notmandatory or significant, and the mechanisms that implement theinvention or its features may have different structural construct,names, and divisions. Accordingly, the disclosure of the invention isintended to be illustrative, but not limiting, of the scope of theinvention.

While the invention has been described in terms of several embodiments,those of ordinary skill in the art will recognize that the invention isnot limited to the embodiments described, but can be practiced withmodification and alteration within the spirit and scope of the appendedclaims. The description is thus to be regarded as illustrative insteadof limiting. There are numerous other variations to different aspects ofthe invention described above, which in the interest of conciseness havenot been provided in detail. Accordingly, other embodiments are withinthe scope of the claims.

The invention has been described in relation to particular examples,which are intended in all respects to be illustrative rather thanrestrictive. Those skilled in the art will appreciate that manydifferent combinations will be suitable for practicing the presentinvention. Other implementations of the invention will be apparent tothose skilled in the art from consideration of the specification andpractice of the invention disclosed herein. Various aspects and/orcomponents of the described embodiments may be used singly or in anycombination. It is intended that the specification and examples beconsidered as exemplary only, with a true scope and spirit of theinvention being indicated by the following.

What is claimed is:
 1. A percutaneous intervention system comprising: abifurcated catheter comprising a first procedural lumen and a secondstabilization lumen at a distal end, wherein the bifurcated catheterinsertable through a first percutaneous access and guidable to thelocation of an access to a treatment site; a procedural catheterslideably insertable through the first procedural lumen and configuredto be delivered to the treatment site for a catheter interventionprocedure; and a stabilization wire insertable through a secondpercutaneous access, wherein a distal end of the stabilization wire isconfigured to be captured by a snare wire slidably insertable throughthe stabilization lumen of the bifurcated catheter and pulled out of aproximal end of the bifurcated catheter at the first percutaneous accesswhile a proximal end of the stabilization wire is outside the secondpercutaneous access; wherein the stabilization wire is configured toprovide an end to end tension capability on application of a tensionbetween the proximal end and distal end of the stabilization wire,wherein the stabilization wire is configured to stabilize the bifurcatedcatheter when tension is applied between the proximal end and distal endof the stabilization wire to provide the end to end tension capability,and wherein the procedural catheter is slideably insertable through thefirst procedural lumen and wherein the procedural catheter is configuredto be stabilized during access to the procedural site and duringprocedures by the stabilized, bifurcated catheter.
 2. The percutaneousintervention system of claim 1, wherein the percutaneous interventionsystem is configured to be implemented in at least one of the followingprocedures: a carotid stenting procedure, an external carotid procedureor an intracranial procedure.
 3. The percutaneous intervention system ofclaim 2, wherein the first percutaneous access is a percutaneous femoralaccess and the second percutaneous access is a percutaneous radialartery access.
 4. The percutaneous intervention system of claim 2,wherein a bifurcation of the bifurcated catheter is locatable within theaortic arch at an ostium of the carotid artery leading to the treatmentsite.
 5. The percutaneous intervention system of claim 1, wherein thepercutaneous intervention system is configured to be implemented in atleast one of the following procedures: a renal stenting procedure, or aprocedure for treatment of a renal disease.
 6. The percutaneousintervention system of claim 5, wherein the first percutaneous access isa percutaneous femoral access and the second percutaneous access is apercutaneous radial artery access.
 7. The percutaneous interventionsystem of claim 5, wherein a bifurcation of the bifurcated catheter islocatable within the aorta at an ostium of a renal artery leading to thetreatment site.
 8. The percutaneous intervention system of claim 1,wherein the catheter intervention system is configured to be implementedin a treatment of at least one of the following: a contralateral lowerextremity peripheral arterial disease, a cancer, a spenic arterialdisease or other visceral artery diseases.
 9. The percutaneousintervention system of claim 1, wherein the procedural catheter isconfigured to be implemented in at least one of the followingprocedures: a steep aortobifemoral bypass graft, renal intervention,SMA, stenting, and cancer hepatic embolization.
 10. A percutaneousintervention system comprising: a sheath catheter configured forpercutaneously insertion from a first access; wherein at least a portionof the sheath catheter comprises a reinforced section; a stabilizationelement comprising a grasping attachment insertable through a secondpercutaneous access, wherein the grasping attachment is configured toengage with the reinforced section of the sheath catheter to provide astabilization to the sheath catheter; and a procedural catheterconfigured to access a treatment site for percutaneous interventiontreatment through the stabilized sheath catheter stabilized by thestabilization element.
 11. The percutaneous intervention system of claim10, wherein the stabilization element comprises a stabilizationcatheter.
 12. The percutaneous intervention system of claim 10, whereinthe stabilization element comprises a stabilization wire.
 13. Thepercutaneous intervention system of claim 10, wherein the reinforcedsection comprises a ferro-magnetic material.
 14. The percutaneousintervention system of claim 13, wherein the grasping attachmentcomprises a magnetic latching mechanism.
 15. The percutaneousintervention system of claim 10, wherein the sheath catheter comprises areverse curve catheter.
 16. The percutaneous intervention system ofclaim 10, wherein the percutaneous intervention system is configured tobe implemented in at least one of the following procedures: acontralateral lower extremity peripheral arterial disease, a renaldisease, a cancer, a spenic arterial disease or other visceral arterydiseases.
 17. The percutaneous intervention system of claim 10, furthercomprising a procedural catheter configured to be delivered to atreatment site through the sheath catheter, which is engaged andstabilized by the stabilization element.
 18. The percutaneousintervention system of claim 10, wherein the procedural catheter isconfigured to be implemented in at least one of the followingprocedures: a steep aortobifemoral bypass graft, renal intervention,SMA, stenting, and cancer hepatic embolization.
 19. The percutaneousintervention system of claim 10, wherein the catheter interventionprocedure comprises at least one of the following procedures: a carotidstenting procedure, an external carotid procedure or an intracranialprocedure.